Comparison of Two Types of Face Mask Ventilation in Obese Patients

A Comparison of Two Types of Face Masks: Cuffed and Uncuffed for Ventilation of Obese Patients

Two types of face masks : cuffed and uncuffed were evaluated for artificial ventilation in obese patients. After induction to anesthesia patients were ventilated with both types of masks using anesthesia machine with the same settings: Tital Volume of 500 ml, respiratory rate of 12/min. The inspired and expired volume was measured using anesthesia machine volumeter, The difference between inspired and expired volume was counted. The comparison between two types of masks was performed taking into consideration several parameters: type of obesity, gender, age.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Other: Ventilation using two types of face masks

Detailed Description

The aim of the study was to determine which of the tested: cuffed or uncuffed face masks allows better replacement ventilation in obese patients.

The study was conducted on patients with the BMI over 39 kg/m2 Patients qualified for bariatric surgery were selected for this study according to the order of reporting to the surgery department. The study adopted a simplified assumption that the gynoid type of obesity most often concerns women, and the android type, i.e. abdominal obesity, most often affects men. Two face masks were used to compare the effectiveness of replacement ventilation: the cuffed and uncuffed . It was randomly chosen (by tossing a coin) which face mask would be used first. The induction of anesthesia was low-opioid, the patients were placed in the supine position with the head and trunk elevated by 25 degrees on a positioning pad. 100% oxygen concentration was used for active pre-oxygenation, the test mask was applied with one hand using the EC clamp technique. The masks were changed after four consecutive measurements for each type of mask. In order to objectify the measurement with the same tidal volume, a respirator was used with the same settings: Tidal Volume of 500 ml and respiratory rate of 12/min. Sealing was measured by comparing the inspired volume with expired volume, that is the amount of leakage generated by individual masks was assessed. The obtained data were analyzed with the Kolmogorow-Smirnov test and supplemented with the values of the Wilcoxona test.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 90-153
    • Medical University of Lodz, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• obesity
• scheduled for elective surgery under general anesthesia

Exclusion Criteria:

• predicted difficult intubation
• predicted difficult face-mask ventilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cuffed face amsk; Ventilation using cuffed face mask	Other: Ventilation using two types of face masks; ventilation using two types of face mask
Experimental: Uncuffed face mask; Ventilation using uncuffed face mask	Other: Ventilation using two types of face masks; ventilation using two types of face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sealing of face masks measured by difference of inspired tidal volume and expired volume	Sealing of cuffed or uncuffed masks during face mask ventilation in obese patients measred by anesthesia machine	immediatethrough study completion

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Principal Investigator: Tomasz Gaszynski, Prof, Medical University of Lodz, Poland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: morbid obesity; face mask ventilation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: RNN/96/13/KB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No